OVERVIEW : The YCC is committed to the highest level of performance of clinical research conducted under its auspices. To guarantee this commitment, the YCC provides ongoing oversight of all clinical studies to ensure the safety of participants;integrity of the data;and adherence to all Federal regulations, Good Clinical Practices, and University policies related to the conduct of clinical research. This critical oversight is provided by the YCC Quality Assurance, Compliance and Safety (QUACS) and the YCC Oversight Committees (OC) and is supported by the YCC Director and Senior Leadership. Data and safety monitoring reviews are conducted on all studies in accordance with the Data and Safety Management Plan (DSMP) for the individual study. This plan is designated at the time of original review by the Protocol Review Committee as outlined in further detail in Section 9.2.